Medical Device Cleanrooms

American Cleanroom Systems is an expert on medical device, pharmaceutical, nutraceuticals and medical supplier cleanrooms.

Past industry clients have included:

  • Allergan – Sterile fill room
  • Baxter
  • DuPont
  • Johnson & Johnson
  • K C Pharmaceutical
  • Medtronic
  • Siemens
  • ISTA Pharmaceutical
  • Hartley Pharmacy USP797 cleanroom
  • Long Beach Memorial Hospital USP 797 pharmacy cleanroom
  • Meditech compounding cleanroom
  • Nutraceuticals mfg
  • Medical plastics injection molders
  • And More

American Cleanroom Systems has a track record of delivering clean room solutions for a large number of world-class medical related companies. We deliver on time and on budget at very competitive prices. Contact us today and we’ll discuss your requirements and submit a project quote within 48 hours.

Common Cleanroom Class Choices

Type of ProcessCleanroom Class
Aseptic manufacturing and fillingClass 100/ISO5
Assembly and packaging of devices that will be terminally sterilized where low particle count on devices is desiredClass 10,000/ISO7
Convenience kits and assembly of medical  devices that need to be free of visible particlesClass 100,000/ISO8/controlled environment
Manufacturers that repackage and/or re-label unpackaged bulk devices contract sterilizers, and re-manufacturers that change the original condition of devices,Subject to QS (Quality Systems)/GMP (Good Manufacturing Practices)
Pharmacy Drug compounding (per USP website)Class 100 hood in class 10k room
MonitoringMethod
Air – Particle countAir sampler (particle counter)
Work surfaces – microbesSurface contact plates or settling plates
Regulations
Airborne particulate cleanlinessFED-STD-209E
Personnel training 820.25 ( QS)
Buildings21 CFR 820.70 (QS)
Cleaning ProceduresCFR 820.70 (QS)
Pharmacy Drug compoundingUSP797

Per FDA factors to consider when planning and using a controlled environment:

  • proper attire and dressing anteroom;
  • controlled use of, and entry into, controlled areas;
  • prohibiting eating, drinking, smoking, or gum chewing;
  • preventing use of lead pencils;
  • regulating the storage of glassware and containers;
  • preventing or controlling the cutting, tearing or storage of cardboard, debris, etc.;
  • cleaning the room and production equipment per written procedure;
  • the original design and cleaning of work surfaces and chairs;
  • selecting correct furniture and eliminating all nonessential equipment;
  • controlling room air quality (amount of particulates, pressure, velocity, and exchange rate);
  • eliminating electrostatic charges by controlling work surface composition or grounding;
  • ensuring cleanliness of raw materials, components and tools;
  • controlling the purity, sterility, and non­pyrogenicity of process water; and
  • maintaining prefilters, HEPA filters, and electrostatic precipitators.

American Cleanroom Systems modular clean room walls made of FRP (reinforced plastic) and HPL (high pressure laminate) are often used in pharmaceutical, USP 797 compounding rooms, and medical device clean rooms. They can be wiped down with antiseptic. This wall system is an economical and cost effective method to achieve the FDA GMP 9 (QS) and USP 797.

American Cleanroom Systems also offers standard built seamless epoxy coated cleanroom walls with coved flooring to handle more robust mop down wall cleaning/disinfectant procedures.